Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

This study is currently recruiting participants.

Verified by Mitsubishi Tanabe Pharma Corporation, August 2009

First Received: October 24, 2008 Last Updated: August 17, 2009 History of Changes

Sponsors and Collaborators:	Mitsubishi Tanabe Pharma Corporation Vertex Pharmaceuticals Incorporated
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00780416

Purpose

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with genotype 1 hepatitis C.

Condition	Intervention	Phase
Hepatitis C	Drug: MP-424 Drug: Ribavirin Drug: Peginterferon Alfa-2b	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2b Telaprevir

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Undetectable HCV RNA at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: After 24 weeks of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event, Adverse drug reaction [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	165
Study Start Date:	October 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MP-424 750 mg q8h for 12 weeks Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks
2: Active Comparator	Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Genotype 1, chronic hepatitis C
Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
Able and willing to follow contraception requirements

Exclusion Criteria:

Cirrhosis of the liver or hepatic failure
Hepatitis B surface antigen-positive or HIV antibodies-positive
History of, or concurrent hepatocellular carcinoma
History of, or concurrent depression, schizophrenia; or suicide attempt in the past
Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780416

Contacts

Contact: Clinical Trials Information Desk

cti-inq-ml@ml.mt-pharma.co.jp

Locations

Japan, Tokyo
Toranomon Hospital	Recruiting
Minato-ku, Tokyo, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Vertex Pharmaceuticals Incorporated

Investigators

Study Director:	Kazuoki Kondo, MD	Mitsubishi Tanabe Pharma Corporation
Study Director:	Tadashi Yoshida, MD	Mitsubishi Tanabe Pharma Corporation

More Information

No publications provided

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( General Manager, Clinical Research Department III )
Study ID Numbers:	G060-A6
Study First Received:	October 24, 2008
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00780416 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic Hepatitis C
Protease Inhibitor
Telaprevir
Peginterferon Alfa-2b
Ribavirin

Study placed in the following topic categories:

Antimetabolites
Interferon-alpha
Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents

Protease Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2b
Interferon Alfa-2b
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on September 01, 2009